Background: There is an increasing need to integrate patient-generated health data (PGHD) into health information systems (HISs). The use of health information standards based on the dual model allows the achievement of semantic interoperability among systems. Although there is evidence in the use of the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) framework for standardized communication between mobile apps and electronic health records (EHRs), the use of European Norm/International Organization for Standardization (EN/ISO) 13606 has not been explored yet, despite some advantages over FHIR in terms of modeling and formalization of clinical knowledge, as well as flexibility in the creation of new concepts. Objective: This study aims to design and implement a methodology based on the dual-model paradigm to communicate clinical information between a patient mobile app (Xemio Research) and an institutional ontology-based clinical repository (OntoCR) without loss of meaning. Methods: This paper is framed within Artificial intelligence Supporting CAncer Patients across Europe (ASCAPE), a project that aims to use artificial intelligence (AI)/machine learning (ML) mechanisms to support cancer patients’ health status and quality of life (QoL). First, the variables “side effect” and “daily steps” were defined and represented with EN/ISO 13606 archetypes. Next, ontologies that model archetyped concepts and map them to the standard were created and uploaded to OntoCR, where they were ready to receive instantiated patient data. Xemio Research used a conversion module in the ASCAPE Local Edge to transform data entered into the app to create EN/ISO 13606 extracts, which were sent to an Application Programming Interface (API) in OntoCR that maps each element in the normalized XML files to its corresponding location in the ontology. This way, instantiated data of patients are stored in the clinical repository. Results: Between December 22, 2020, and April 4, 2022, 1100 extracts of 47 patients were successfully communicated (234/1100, 21.3%, extracts of side effects and 866/1100, 78.7%, extracts of daily activity). Furthermore, the creation of EN/ISO 13606–standardized archetypes allows the reuse of clinical information regarding daily activity and side effects, while with the creation of ontologies, we extended the knowledge representation of our clinical repository. Conclusions: Health information interoperability is one of the requirements for continuity of health care. The dual model allows the separation of knowledge and information in HISs. EN/ISO 13606 was chosen for this project because of the operational mechanisms it offers for data exchange, as well as its flexibility for modeling knowledge and creating new concepts. To the best of our knowledge, this is the first experience reported in the literature of effective communication of EN/ISO 13606 EHR extracts between a patient mobile app and an institutional clinical repository using a scalable standard-agnostic methodology that can be applied to other projects, data sources, and institutions.

Purpose: To assess the usability and preferences of the contents of mHealth software developed for breast cancer patients as a tool to obtain patient-reported outcomes (PROMs), improve the patient’s knowledge about the disease and its side effects, increase adherence to treatment, and facilitate communication with the doctor. Intervention: an mHealth tool called the Xemio app provides side effect tracking, social calendars, and a personalized and trusted disease information platform to deliver evidence-based advice and education for breast cancer patients. Method: A qualitative research study using semi-structured focus groups was conducted and evaluated. This involved a group interview and a cognitive walking test using Android devices, with the participation of breast cancer survivors. Results: The ability to track side effects and the availability of reliable content were the main benefits of using the application. The ease of use and the method of interaction were the primary concerns; however, all participants agreed that the application would be beneficial to users. Finally, participants expressed their expectations of being informed by their healthcare providers about the launch of the Xemio app. Conclusion: Participants perceived the need for reliable health information and its benefits through an mHealth app. Therefore, applications for breast cancer patients must be designed with accessibility as a key consideration.

PURPOSE: To comprehensively synthesize the existing evidence concerning mHealth interventions for patients with breast cancer (BC). DESIGN: On July 30, 2023, we searched PubMed, PsycINFO, and Google Scholar for articles using the following inclusion criteria: evaluation of mHealth interventions in patients with cancer, at least 30 participants with BC, randomized control trials or prospective pre-post studies, determinants of health (patient-reported outcomes [PROs] and quality of life [QoL]) as primary outcomes, interventions lasting at least 8 weeks, publication after January 2015. Publications were excluded if they evaluated telehealth or used web-based software for desktop devices only. The quality of the included studies was analyzed with the Cochrane Collaboration Risk of Bias Tool and the Methodological Index for Non-Randomized Studies. RESULTS: We included 30 studies (20 focused on BC), encompassing 5,691 patients with cancer (median 113, IQR, 135.5). Among these, 3,606 had BC (median 99, IQR, 75). All studies contained multiple interventions, including physical activity, tailored information for self-management of the disease, and symptom tracker. Interventions showed better results on self-efficacy (3/3), QoL (10/14), and physical activity (5/7). Lifestyle programs (3/3), expert consulting (4/4), and tailored information (10/11) yielded the best results. Apps with interactive support had a higher rate of positive findings, while interventions targeted to survivors showed worse results. mHealth tools were not available to the public in most of the studies (17/30). CONCLUSION: mHealth interventions yielded heterogeneous results on different outcomes. Identifying lack of evidence on clinical scenarios (eg, patients undergoing systemic therapy other than chemotherapy) could aid in refining strategic planning for forthcoming research endeavors within this field.

BACKGROUND The field of mHealth has grown exponentially in the last decade due to the widespread use of smartphones and the advancements in mobile technology, which has created opportunities to find solutions to unmet healthcare needs for patients with chronic diseases. Furthermore, healthcare is entering a new value-based paradigm, founded on three main pillars: efficiency, safety, and value for patients. OBJECTIVE The objective of this study is to evaluate the effectiveness of mHealth interventions in the treatment of BC, considering factors such as the duration of the intervention, the type of intervention, the patient subtype, and the analyzed outcomes. The study aims to identify which mHealth interventions are more effective for treating BC in different patient subtypes, and how these interventions affect clinical outcomes in terms of symptom improvement, and quality of life. METHODS Three databases were systematically searched to identify studies that met eligibility criteria: PubMed, PsychInfo, and Google Scholar. Inclusion criteria were: evaluation of the use of mHealth in cancer patients, at least 30 participants with breast cancer, randomized control trials or prospective pre-post studies, inclusion of PROs, QoL or other determinants of health as primary outcomes, minimum duration of intervention of 8 weeks, dato of publication after 2015. Publications were excluded if they evaluated telehealth or used web-based software for desktop devices only. Relevant systematic reviews and the references of the research articles they contained were also searched in case that studies were missed during the initial search. Searches were made on December 17th, 2021. Two investigators independently reviewed the titles and abstracts of the identified studies and then read the full text of all selected papers. In case a discrepancy was found, it was discussed with a third investigator in order to make a final decision. The quality of the included studies was analyzed by the Cochrane Collaboration Risk of Bias Tool and the Methodological Index for Non-Randomized Studies. RESULTS Twenty-two unique studies involving 3,502 patients were included. The focus of the interventions in the studies included in the review were physical activity (11 studies), tailored information for better self-management of the disease (8 studies), mental health therapies (6 studies), symptom tracker (4 studies), and others (6 studies). All interventions were at least 8 weeks long, with a median duration of 12 weeks (interquartile range 4-18 weeks). mHealth interventions showed better results on symptom burden, fatigue, quality of life and physical activity. Likewise, tailored information, symptom tracker, nutrition and physical activity were the interventions that yielded better results. Apps with interactive support had a higher rate of positive findings, while interventions targeted to survivors showed worse results. CONCLUSIONS mHealth applications in BC patients is a highly heterogeneous field. Our study suggests that interventions focused on newly diagnosed patients or patients while on chemotherapy, interventions with interactive human support and those with a duration of 12 weeks or more showed better results in terms of patient-reported outcome. Interventions must be adapted to each patient’s characteristics and disease stage to meet their specific needs at the time of deployment. Positive impact on endpoints shows what can be achieved with the right mHealth intervention. The reproducibility of the studies reporting mHealth interventions is currently uncertain. CLINICALTRIAL PROSPERO CRD42022341598; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022341598

PURPOSE: We evaluated whether offering access to a multicomponent mHealth app improves quality of life (QoL) and psychosocial outcomes among breast cancer survivors under pragmatic, nonprescriptive conditions. METHODS: In this single-center, randomized, controlled trial at Hospital Clínic de Barcelona, women age ≥18 years, disease-free after breast cancer treatment, were recruited (December 2020-December 2021) and randomly assigned 1:1 to usual follow-up plus app access or usual follow-up alone. The app provided CTCAE v4.03-aligned symptom tracking with self-care guidance, educational content, an events calendar, and gamified smartphone-based step counting; no protocolized clinician monitoring or feedback was provided. Outcomes were assessed at baseline and 3, 6, 9, and 12 months using European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (QLQ)-C30/BR23, Hospital Anxiety and Depression Scale (HADS), and Three-Item Loneliness Scale (TILS). The primary end point was the difference in QLQ-C30 Global Health Status/QoL at 3 months. Analyses followed intention-to-treat using mixed models for repeated measures adjusted for baseline values. RESULTS: Of 124 women assessed, 121 were randomized (intervention n = 60; control n = 61). Patient-reported outcome measures were available for 106 of 121 (87.6%) at 3 months and 95 of 121 (78.5%) at 12 months. At 3 months, there was no significant difference in Global Health Status/QoL (adjusted mean difference [Intervention-Control], -2.24 [95% CI, −9.29 to 4.81]; P = .53); estimates at later time points were similarly imprecise. No significant between-group difference were observed for QLQ-BR23 domains, HADS anxiety/depression, or TILS. Exploratory subgroup analyses suggested possible heterogeneity in TILS by hormonal-treatment category; this was descriptive and hypothesis-generating only. App engagement was the highest in months 0-3 (48/60 [80.0%] with any use) and declined thereafter; 12 of 60 (20.0%) never used the app. CONCLUSION: In a pragmatic, nonprescriptive survivorship trial, offering access to a multicomponent mHealth app without closed-loop clinical integration did not show a statistically significant between-group differences in QoL or psychosocial outcomes; confidence intervals were compatible with meaningful harm and did not exclude small benefit depending on the threshold used to define clinical relevance.

BACKGROUND There is an increasing need to integrate patient-generated health data into health information systems. The use of health information standards based on the dual model allows the achievement of semantic interoperability among systems. This article is framed within ASCAPE, a project that aims to employ Artificial Intelligence / Machine Learning mechanisms to support cancer patients’ health status and quality of life. OBJECTIVE To design and implement a methodology based on the dual model paradigm to communicate clinical information between a patient mobile app (Xemio) and an institutional ontology-based clinical repository (OntoCR) without loss of meaning. METHODS First, the variables to be communicated were defined and represented in both systems. Then, EN/ISO 13606 archetypes were created, and local concepts were modeled conforming to the standard in OntoCR and in Xemio. Extracts were sent to an API in OntoCR, which maps each element in the normalized XML files to its corresponding location in the ontology. In this way, instantiated data of patients are stored in the clinical repository. RESULTS Between December 22, 2020 and April 4, 2022, 1,100 extracts of 47 patients were successfully communicated (234 of secondary effects and 866 of daily activity). Furthermore, the creation of EN/ISO 13606-standardized archetypes allows the reuse of clinical information regarding daily activity and secondary effects, while with the creation of ontologies we extended the knowledge representation of our clinical repository. CONCLUSIONS Health information interoperability is one of the requirements for continuity of healthcare. The dual model allows the separation of knowledge and information in health information systems. EN/ISO 13606 was chosen for this project because of the operational mechanisms it offers for data exchange. To the extent of our knowledge, this is the first experience reported in the literature of effective communication of EN/ISO 13606 electronic health record (EHR) extracts between a patient mobile application and an institutional clinical repository.